Guselkumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo
Näytönastekatsaukset
15.6.2020
Level of evidence: B
Guselkumab treatment when compared to placebo, seems to increase the proportion of patients with moderate to severe plaque psoriasis to achieve a clinically meaningful improvement at 12 weeks of treatment.
It might be that there are not more adverse events in guselkumab treatment compared to placebo after 12 weeks of treatment but the level of evidence is low. The evidence is mainly based on 2 phase III RCT’s.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias «Guselkumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo»1 |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; MA=meta-analysis; PGA/IGA=physician's Global Assessment / investicator Golbal Assessment; PASI=psoriasis area severity index | |||||
| «Bilal J, Berlinberg A, Bhattacharjee S ym. A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, bro»1 | MA | RCTs, adults (> 18 years) with moderate to severe plaque psoriasis treated with biologic agents. N=1497 | Guselkumab 100 mgvs. Placebo | Primary: PASI-75, PGA 0-1 at 12-16 weeks Secondary: PASI-90, safety | low |
| «Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 »2 | MA, Network analysis | RCTs of systemic and biological treatments in adults (>18 years) with moderate to severe plaque psoriasis, at any stage of treatment, incomparison to placebo or another active agent. | Primary: PASI-90, serious adverse effects. Secondary: PASI-75, PGA0-1, DLQI, adverse events. | In one study high risk of bias: blinding | |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval | |||||
| «Bilal J, Berlinberg A, Bhattacharjee S ym. A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, bro»1 | 3 RCTs,867 / 464 | 16 weeks, outcomes reported at 12 weeks | 733 (84.5) | 36 (7.8) | Risk ratio10.8 (7.9-14.9) |
| Level of evidence: moderate The quality of evidence is downgraded due to study limitations. | |||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| «Bilal J, Berlinberg A, Bhattacharjee S ym. A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, bro»1 | 3 RCTs,867 / 464 | 16 weeks, outcomes reported at 12 weeks | 516 (60,5) | 17 (3,7) | Risk ratio27.2 (15.5-47.6) |
| «Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 »2 | 3 RCTs, N=1502 | 12-16 weeks | NA | NA | RR 21.03 (14.56 to 30.38) |
| Level of evidence: moderate The quality of evidence is downgraded due to study limitations and indirectness (secondary outcome). | |||||
References
- Bilal J, Berlinberg A, Bhattacharjee S ym. A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab and tildrakizumab for the treatment of moderate to severe plaque psoriasis. J Dermatolog Treat 2018;29:569-578 «PMID: 29532693»PubMed
- Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 «PMID: 29271481»PubMed